Trial Outcomes & Findings for Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases (NCT NCT03498612)

Last Updated: 2025-11-12

Results Overview

Measured by Lugano Criteria evaluated by positron emission tomography (PET)/computed tomography (CT) or CT or white blood cell count for chronic lymphocytic leukemia (CLL). The corresponding 95% two-sided confidence interval will be derived.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to 8 months.

Results posted on

2025-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (pembrolizumab) Patients receive pembrolizumab 200mg IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=10 Participants
Age, Categorical >=65 years	4 Participants n=10 Participants
Age, Continuous	55 years n=10 Participants
Sex: Female, Male Female	3 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants
Race (NIH/OMB) White	9 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Region of Enrollment United States	9 participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 8 months.

Outcome measures

Outcome measures
Measure	Treatment (pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Response Rate (Complete Response [CR] + Partial Response [PR] for Follicular Lymphoma and Marginal Zone Lymphoma)	3 Participants

SECONDARY outcome

Timeframe: From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years

Kaplan Meier methodology will be used to estimate event-free curves.

Outcome measures

Outcome measures
Measure	Treatment (pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Duration of Response	41 Months Interval 4.0 to 60.0

SECONDARY outcome

Timeframe: From the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years

Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.

Outcome measures

Outcome measures
Measure	Treatment (pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Progression-free Survival	6.3 Months Interval 3.77 to The upper limit of the 95% confidence interval could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the time of first study drug administration until the date of the first subsequent therapy given to treat the indolent B-cell non-Hodgkin lymphoproliferative diseases, assessed up to 5 years

Outcome measures

Outcome measures
Measure	Treatment (pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Time to Next Therapy	5.4 Months Interval 4.73 to The upper limit of the 95% confidence interval could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 90 days after last dose, up to 1 year.

Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug.

Outcome measures

Outcome measures
Measure	Treatment (pembrolizumab) n=9 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Count of Participants Who Experience Adverse Events (AEs)	9 Participants

Adverse Events

Treatment (pembrolizumab)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (pembrolizumab) n=9 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
General disorders Rituximab Desensitization Protocol	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Injury, poisoning and procedural complications Retroperitoneal Venous Hemorrhage	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.

Other adverse events

Other adverse events
Measure	Treatment (pembrolizumab) n=9 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Gastrointestinal disorders Abdominal Pain	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders ACTH decreased	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Number of events 6 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Investigations Alkaline phosphatase increased	22.2% 2/9 • Number of events 2 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Number of events 3 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Musculoskeletal and connective tissue disorders Back Pain	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Investigations Blood bilirubin increased	22.2% 2/9 • Number of events 2 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
General disorders Chills	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Number of events 2 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Eye disorders Dry Eye	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Skin and subcutaneous tissue disorders Dry Skin	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Gastrointestinal disorders Dry Mouth	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
General disorders Edema limbs	22.2% 2/9 • Number of events 2 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders Elevated TSH	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
General disorders Fatigue	66.7% 6/9 • Number of events 6 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
General disorders Fever	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders Elevated T3	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders Elevated T4	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Metabolism and nutrition disorders Hyperglycemia	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders Hyperthyroidism	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Number of events 4 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Musculoskeletal and connective tissue disorders Left shoulder pain	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Gastrointestinal disorders Nausea	22.2% 2/9 • Number of events 2 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Skin and subcutaneous tissue disorders Pruritis	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Skin and subcutaneous tissue disorders Right forehead pink papule	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
General disorders Right lower rib pain	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Reproductive system and breast disorders Scrotal edema	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Infections and infestations Left foot fungal infection	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.
Endocrine disorders Testosterone decreased	11.1% 1/9 • Number of events 1 • From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year. Method of routinely determining whether or not certain adverse events have occurred happen through regular investigator assessment, regular laboratory testing, and patient self-reporting.

Additional Information

Ajay Gopal, MD

University of Washington

Phone: 206-606-2037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place